# K252890: ZenSeal Pro

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Jan 7, 2026 after 118 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K990131 (1999). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190503: CeraSeal, Meta Biomed Co., Ltd. (2019) Summary page 5.
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 5.

## Indications for use
Permanent obturation of the root canal. ZenSeal Pro is intended for root canal sealing after the removal of infected or necrotic pulp tissue. ZenSeal Pro is suitable for use in the warm vertical condensation, single cone, cold lateral condensation and gutta-percha carrier obturator technique.

Source page: https://510kreport.com/device/K252890
Methodology: https://510kreport.com/methodology